12 month Validation Engineering contract available in pharmaceutical manufacturer in south-east Ireland
The Opportunity:
In the Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes.
The following activities will be included as part of your role.
Main responsibilities:
The following activities will be included as part of your role:
· Designing, executing and reporting on PV/Process Performance Qualifications.
· Designing, executing and reporting on validation studies for equipment, systems and processes.
· Ensuring validation studies are managed in conjunction with all required company standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
· Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation
· Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times
· Maintaining validation documentation through the validation lifecycle
· Participation in external regulatory inspections
· Support Site Change Control process
About you
Experience: 3-5 years' experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
Soft skills:
· Natural influencer and works well as part of a multifunctional team.
· Highly motivated and self-resilient.
· Adaptable and flexible as well as a pragmatically minded problem solver.
· Sees projects/tasks through to completion.
Technical skills:
· Capable of troubleshooting validation issues associated with projects, process development etc.
· Competent technical knowledge of pharmaceutical plants.
· Previous validation/product development experience would be highly advantageous for the role.
· Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
· Knowledge of requirements for of GAMP, ISPE Baseline guides.
· Knowledge of steam and dry heat validation publications such as American National Standards, PDA and ISO guidelines.
· Full understanding of relevant quality and compliance regulations
· Able to execute projects to plan.
· Good knowledge of quality management systems.
· Good communication skills at organisation, team and individual levels.
· Ability to use MS Project and SPC packages an advantage
· Understands KPI's for the site.
Education: Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)
Languages: English
For more information on this position please contact Jenny Navan via phone or email in Cpl
Cpl are an equal opportunities employer.
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